Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT) Training
Focus Area: Capacity Building
Focus Area: Current Project
Consistent with the goals of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulatory authorities worldwide wish to ensure that drugs, biologics and devices are developed by processes that uphold the highest ethical standards and scientific principles.
These processes depend upon consensus understanding of the principles underlying drug development, clinical and research practices, regulatory review of submitted data, regulatory inspections and post-approval monitoring. Further, evolving technologies, capacities, and study design require periodic review and adaptation of the ICH guidelines. Harmonized technical guidelines to which global regulators commit can speed the process for efficient and effective registration, approval, and monitoring. A shared interpretation of these guidelines is essential to a cooperative and global effort to promote and protect public health.
The MRCT Center has been endorsed by ICH as a training partner and designated as an Asia-Pacific Economic Cooperation (APEC) Training Center of Excellence. In 2017 and 2018 the MRCT Center hosted two pilot trainings with a focus on the global standards published by the ICH that address best practices for the design, conduct, and oversight of clinical trials. The goals of these multi-day training workshops were to build local regulatory capacity, particularly in emerging economies, in good clinical practices (GCP, ICH E6(R2)) and to facilitate review and oversight of multi-regional clinical trials (MRCTs, ICH-E17). The trainings were in-person, interactive, and case-based, facilitated by senior professionals from the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Health Canada, Health Products Regulatory Authority (HPRA) Ireland, Pharmaceuticals and Medical Devices Agency (PMDA, Japan), industry partners and MRCT Center Leadership. In 2019, the MRCT Center conducted a multi-day training workshop focused on ICH GCP and MRCT guidelines at an in-country training in Canada. In February of 2020, the MRCT Center launched a 10- module online course on “Interpretation and Application of ICH E6(R2).” The online course is an introductory training that targets a wide audience including regulators, sponsors, IRBs, and clinical sites. The online course is freely accessible. Since the launch of this online course, the MRCT Center has been approached by several economies to conduct customized trainings.
Current status: Active project
Impact: Improved regulatory capacity to provide a unified standard for conducting and oversight of clinical trials.
Learning Objectives:
- Describe the standards of Good Clinical Practice (GCP) and key considerations in Multi-Regional Clinical Trials (MRCTs) design as set out in ICH E6(R2) and ICH E17 guidance, respectively.
- Describe models of implementation of the changes in the ICH E6(R2) addendum and ICH E17 guidance to increase the acceptability of MRCT data by multiple regulatory authorities.
- Demonstrate practical approaches to fulfilling the requirements of ICH E6(R2) and ICH E17 consistent with ICH standards.
- Describe and demonstrate best practices to assess clinical trial regulatory submissions, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP and MRCT.
- Define inspection methodologies to assess clinical trial conduct for alignment with ICH GCP and MRCT standards, including review of corrective actions.
Deliverables:
- ICH GCP Pilot Training
- APEC Pilot Center of Excellence Training on MRCT and GCP
- GCP and MRCT Training in Canada
- Online training on ICH E6(R2) GCP
Key Milestones:
- November 2021: Since the launch of “Interpretation and Application of ICH E6(R2)” online, over 2,200 individuals from 90+ countries enrolled, and nearly 1,400 individuals completed all 10 modules
- May-June 2021: Conducted human participant clinical research virtual training for pharmacy and biotechnology engineering students in Algeria
- March 2021: One year after the launch of the online course, more than 1,500 individuals from 81 countries enrolled in at least one module, nearly 12,000 modules have been accessed, and more than 930 users completed the 10-module course
- April 2020: During the first two months, approximately 380 unique individuals from around the world enroll in at least one module, just over 2,600 modules have been accessed, and 138 unique users completed the 10-module course
- February 2020: Launched online course “Interpretation and Application of ICH E6(R2)”
- February 2019: Conducted GCP and MRCT training in Ottawa, Canada
- October 2018: MRCT Center designated as APEC LSIF (Life Sciences Innovation Forum) RHSC (Regulatory Harmonization Steering Committee) Training Center of Excellence for Regulatory Science in the area of Multi-regional Clinical Trials and Good Clinical Practice Inspection
- April 2018: Conducted APEC Pilot CoE training on MRCT and GCP at Harvard Faculty Club
- November 2017: MRCT Center endorsed as ICH Training Partner by the ICH Management Committee
- October 2017: ICH GCP Pilot Training at Harvard Faculty Club
- June 2017: First planning committee meeting for APEC Pilot CoE training
- June 2017: Application process opened for ICH GCP pilot training
- May 2017: First planning committee meeting for ICH E6(R2) pilot training
- April 2017: ICH endorsed MRCT Center to conduct ICH GCP pilot training
- February 2017: APEC endorsed MRCT Center as Pilot Center of Excellence for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP)
Project Leadership:
- Barbara E. Bierer, MD, Faculty Director, MRCT Center
- Sarah White, MPH, Executive Director, MRCT Center
Program Managers:
- Carmen Aldinger, PhD, MPH, PMP
- Sylvia Baedorf Kassis, MPH